Single Handled ENT Tool

ABSTRACT

A tool, consisting of an enclosure and a rotatable knob retained by, and protruding from, the enclosure. The tool has a tube having a proximal end that is retained by the enclosure, and the tube has an axis of symmetry. A Geneva drive is retained within the enclosure, the Geneva drive consisting of a drive wheel fixedly attached to the rotatable knob and a driven wheel fixedly attached to the proximal end of the tube, so that an axis of rotation of the driven wheel coincides with the axis of symmetry of the tube. Thus, a continuous rotation of the rotatable knob causes the tube to rotate about the axis of symmetry in discrete angular steps.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication 62/554,894, filed 6 Sep. 2017, which is incorporated hereinby reference.

FIELD OF THE INVENTION

This invention relates generally to surgical tools, and specifically toa surgical tool used for ENT (ear, nose, and throat) procedures.

BACKGROUND OF THE INVENTION

In an ENT procedure involving the sinuses, the configuration of thesinuses typically restricts the freedom of movement of an ENT tool usedto inspect or to operate in the sinuses. A physician may at leastpartially overcome the restriction by using both of his/her hands, butthis requirement may be undesirable to the physician.

SUMMARY OF THE INVENTION

An embodiment of the present invention provides a tool, including:

an enclosure;

a rotatable knob retained by, and protruding from, the enclosure;

a tube having a proximal end retained by the enclosure, the tube havingan axis of symmetry; and

a Geneva drive retained within the enclosure, the Geneva driveconsisting of a drive wheel fixedly attached to the rotatable knob and adriven wheel fixedly attached to the proximal end of the tube, so thatan axis of rotation of the driven wheel coincides with the axis ofsymmetry of the tube,

whereby a continuous rotation of the rotatable knob causes the tube torotate about the axis of symmetry in discrete angular steps.

In a disclosed embodiment the Geneva drive has eight different fixedpositions.

In a further disclosed embodiment the tube has a distal end havingdimensions enabling it to be inserted into an orifice of a humanpatient. The orifice may be a nasal sinus.

There is further provide, according to an embodiment of the presentinvention, a method, including:

providing an enclosure;

positioning a rotatable knob to be retained by, and protrude from, theenclosure;

positioning a tube having a proximal end to be retained by theenclosure, the tube having an axis of symmetry; and

positioning a Geneva drive to be retained within the enclosure, theGeneva drive consisting of a drive wheel fixedly attached to therotatable knob and a driven wheel fixedly attached to the proximal endof the tube, so that an axis of rotation of the driven wheel coincideswith the axis of symmetry of the tube,

whereby a continuous rotation of the rotatable knob causes the tube torotate about the axis of symmetry in discrete angular steps.

The present disclosure will be more fully understood from the followingdetailed description of the embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an ENT (ear, nose, and throat)system, according to an embodiment of the present invention;

FIG. 2 is a schematic diagram of an ENT tool, according to an embodimentof the present invention;

FIG. 3 is a schematic diagram of an ENT tool, according to analternative embodiment of the present invention;

FIGS. 4 and 5 are schematic detail figures of a knob and its internalconstruction, according to an embodiment of the present invention;

FIGS. 6, 7, 8, and 9 are schematic figures illustrating a rotationsystem, according to an embodiment of the present invention;

FIG. 10 and FIG. 11 are schematic illustrations of portions of aguidewire and a balloon insertion mechanism, according to an embodimentof the present invention;

FIG. 12 is a schematic transparent view of a manifold, according to anembodiment of the present invention; and

FIG. 13 is a schematic sectional view of a locking mechanism, accordingto an embodiment of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS Overview

An embodiment of the present invention provides a physician performingan ENT (ear nose and throat) procedure with a balloon sinuplasty toolthat can be held by one hand, and wherein some of the functions of thetool can be implemented by the fingers of the hand. Specifically, whileholding the tool, the physician is able to deflect the distal tip of thetool end away from the tool end axis, and independently rotate the toolend around its axis. The deflection and the rotation can be performed bythe fingers of the hand holding the tool.

In one embodiment of the present invention the tool comprises anenclosure which retains a rotatable knob, so that the knob protrudesfrom the enclosure. The tool also comprises a tube that has an axis ofsymmetry, and that has a proximal end retained by the enclosure. Adistal end of the tube has dimensions enabling it to be inserted into anorifice of a patient.

The enclosure of the tool contains a Geneva drive, which is connected sothat a drive wheel is fixedly attached to the rotatable knob. Inaddition, a driven wheel of the Geneva drive is fixedly attached to thetube proximal end so that an axis of rotation of the driven wheelcoincides with the tube axis of symmetry.

The Geneva drive enables the tube to be rotated, by continuous rotationof the rotatable knob, by discrete angular steps into a number ofdiscrete positions. In each of these positions, even though the knob maycontinue to be rotated, the Geneva drive locks the tube in place so thatit does not rotate. While in any one of these discrete positions, otheroperations may be performed on the tube, such as deflection of thedistal tip from the tool end axis, and the possibility of performingsuch multiple operations simultaneously and independently significantlyassists the physician during a procedure.

The tool also comprises a guidewire insertion mechanism, and a ballooninsertion mechanism. The guidewire and the balloon (of their respectivemechanisms) can be independently threaded through the tool end, andfunctions of the mechanisms can also be independently implemented. Theguidewire comprises a location sensor at its distal tip and typicallythe physician may be able to deflect the guidewire tip.

Typically, after the physician has manipulated the tool end to enableaccess to a desired sinus region, the guidewire is threaded through thetool end, and is manipulated until it is at or beyond the region. Theballoon is then pushed along the guidewire to the region, at which pointit may be inflated to perform sinuplasty.

In addition to the functions listed above, the tool provides channelsfor suction from the distal end, for the inflation of the balloon, andfor irrigation at the distal end.

By incorporating all the above functions into one tool, and by enablingmanipulation of the tool end to be implemented by the one hand holdingthe tool, the physician performing the procedure has substantially morefreedom of movement than in prior art systems.

DETAILED DESCRIPTION

Reference is now made to FIG. 1, which is a schematic illustration of anENT (ear, nose, and throat) system 20, according to an embodiment of thepresent invention. In the following description a single-handed ENT tool21 in system 20 is assumed to be used to perform a balloon sinuplastyprocedure on a patient 22 so that a distal end of the tool is assumed tohave dimensions permitting entry to a nasal sinus of the patient.However, it will be understood that the tool may be used to performother procedures on the patient.

Tool 21 comprises one or more magnetic sensors 32A, 32B, . . . ,generically termed sensors 32, which are typically single axis coils ora triple axis coils, that are tracked during the procedure by a magnetictracking system 23. For the tracking to be effective, in system 20frames of reference of a CT (computerized tomography) image of patient22 and of magnetic tracking system 23, are registered. While the CTimage may typically comprise a magnetic resonance imaging (MRI) image ora fluoroscopic image, in the description herein the image is assumed tocomprise, by way of example, a fluoroscopic CT image.

Prior to and during the sinus procedure, a magnetic radiator assembly24, comprised in the magnetic tracking system, is positioned beneath thepatient's head. Assembly 24 comprises magnetic field radiators 26 whichare fixed in position and which transmit alternating magnetic fieldsinto a region 30 wherein the head of patient 22 is located. Potentialsgenerated by a magnetic sensor such as a given sensor 32 in region 30,in response to the magnetic fields, enable the position and theorientation of the sensor to be measured in the magnetic trackingsystem's frame of reference.

By way of example, radiators 26 of assembly 24 are arranged in anapproximately horseshoe shape around the head of patient 22. However,alternate configurations for the radiators of assembly 24 will beapparent to those having ordinary skill in the art, and all suchconfigurations are assumed to be comprised within the scope of thepresent invention.

Prior to the procedure, the registration of the frames of reference ofthe magnetic tracking system with the CT image may be performed bypositioning a magnetic sensor at known positions, such as the tip of thepatient's nose, of the image. However, any other convenient system forregistration of the frames of reference may be used.

Elements of system 20, including radiators 26 and sensors 32, are underoverall control of a system processor 40. Processor 40 may be mounted ina console 50, which comprises operating controls 58 that typicallyinclude a keypad and/or a pointing device such as a mouse or trackball.Console 50 connects to the radiators and to sensors 32 via one or morecables cable and/or wirelessly. A physician 54 uses operating controls58 to interact with the processor while performing the ENT procedureusing system 20. While performing the procedure, the processor maypresent results of the procedure on a screen 56.

Processor 40 uses software stored in a memory 42 to operate system 20.The software may be downloaded to processor 40 in electronic form, overa network, for example, or it may, alternatively or additionally, beprovided and/or stored on non-transitory tangible media, such asmagnetic, optical, or electronic memory.

FIG. 2 is a schematic diagram of tool 21, according to an embodiment ofthe present invention. Tool 21 comprises a proximal section 80 and adistal section 82 which are connected together, but the distal sectionmay be disassembled and removed from the proximal section. In someembodiments the proximal and/or distal sections are designed to bedisposable, typically after one procedure has been performed.

At its distal end distal section 82 comprises an articulated tubularsection 84, which may be adjustably bent from a straight configuration86 to a curved configuration 88, the latter being schematically shown inthe diagram by broken lines. In the straight configuration tubularsection 84 defines an axis of symmetry 92, which is also an axis ofsymmetry of a tube 100 to which section 84 is connected, as describedbelow. The adjustment from the straight to the curved configuration, andvice versa, may be performed by clockwise and counter-clockwise rotationof a ribbed knob 90, the construction and function of which, and ofentities connected to it, are described further below with respect toFIGS. 4 and 5. U.S. patent application Ser. No. 15/155,850, filed May16, 2016, titled “Insertion Tube with Deflectable Tip,” which isincorporated herein by reference, describes the construction andoperation of a deflectable articulated section such as section 84.

Tubular section 84 is fixedly connected at its proximal end to tube 100which may be rotated about axis of symmetry 92, as indicated by thedouble headed arrow in the figure. The rotation of tube 100 may beimplemented by rotating a ridged knob 106, the knob in turn beingconnected to a rotation system 109 housed in a rotation system enclosure104. Rotation system 109 is described below with respect to FIGS. 6, 7,8 and 9.

Tool 21 comprises a handle 108 which connects to the tool by aball-joint 112. The physician holding the tool is able to adjust thehandle's position according to the physician's preference, and then tolock the handle against the ball-joint by turning a locking knob 116 onthe handle.

Tube 100 and articulated section 84 comprise a central lumen whichpermits the passage of a guidewire 115 and a balloon insertion mechanism119, from proximal section 80, through the lumen. The guidewire and themechanism are described further below, with respect to FIGS. 10 and 11.Proximal sections of the guidewire and the insertion mechanism are heldin place by a manifold 127, which is described with respect to FIG. 12,and the sections may be locked in place, as required, by a lockingmechanism 131 which is described with respect to FIG. 13.

FIG. 3 is a schematic diagram of a tool 121, according to an alternativeembodiment of the present invention. Apart from the differencesdescribed below, the operation of tool 121 is generally similar to thatof tool 21 and elements indicated by the same reference numerals in both21 and 121 are generally similar in construction and in operation.

Tool 121 comprises, in place of handle 108, a ring element 128 whichconnects to a suction tube 124 (described below). The physician usingtool 121 is able to use his/her finger or thumb to hold element 128, andthus hold the tool.

For simplicity and clarity, the remainder of the present applicationassumes tool 21 is used, and those having ordinary skill in the art willbe able to adapt the description, mutatis mutandis, if tool 121 is used.

FIGS. 4 and 5 are schematic detail figures of knob 90 and its internalconstruction, according to an embodiment of the present invention. Knob90, which is hidden in FIG. 5, is rigidly connected by pins 130 to acylinder 134, and the cylinder comprises a first groove 138A and asecond groove 138B at 180° to the first groove, the two grooves beingconfigured as a double-start screw thread. A first pin 142A and a secondpin 142B at 180° to the first pin are mounted on an internal cylinder146 so that pin 142A resides within groove 138A and pin 142B resideswithin groove 138B. Rotation of knob 90 thus causes the knob andcylinder 134 to move in a forward or backward motion parallel to axis92. Cylinder 134 is coupled by an internal element to wires (theinternal element and the wires are not shown in the figures) connectedto distal section 84, so that the motion of the cylinder parallel toaxis 92 causes the distal section to bend to curved configuration 88 orstraighten to straight configuration 86.

FIGS. 6, 7, 8, and 9 are schematic figures illustrating rotation system109, according to an embodiment of the present invention. FIG. 6illustrates a portion of the rotation system with enclosure 104 hidden.FIGS. 7, 8, and 9 illustrate portions of the rotation system with a partof enclosure 104 visible.

As illustrated in FIG. 6, rotation system 109 uses a Geneva drive 114,also termed a Geneva mechanism 114, to rotate tube 100 around axis 92.Knob 106 is fixedly attached to a drive wheel 116 of the mechanism, andthe drive wheel mates with a driven wheel 120 of the mechanism. Drivenwheel 120 is fixedly attached to the proximal end of tube 100 so that anaxis of rotation of the driven wheel coincides with axis of symmetry 92,and so that as the driven wheel rotates, tube 100 rotates about its axisof symmetry.

As shown in FIGS. 7 and 8, drive wheel 116 comprises a pin 122, and alune-shaped element 126. FIG. 7 illustrates driven wheel 120 as seenfrom tube 100, and FIG. 8 illustrates the internal construction of thedriven wheel, showing indentations 130 and slots 134 of the drivenwheel. During rotation of the Geneva drive, indentations 130 are engagedby lune-shaped element 126, and pin 122 engages and travels within slots134. The engagement of pin 122 within a specific slot 134 is illustratedin FIG. 9.

Drive 114 translates continuous rotation of knob 106, typicallyimplemented by a thumb and finger of the hand holding tool 21, intointermittent rotation of tube 100. It will be understood that while tube100 is not being rotated, the engagement of lune-shaped element 126 witha specific indentation 130 locks tube 100 in place, so that the tube isprevented from inadvertent rotation.

By way of example, in the illustrated embodiment driven wheel 120 haseight different fixed positions, corresponding to the eight differentindentations 130, but it will be understood that the scope of thepresent invention comprises Geneva drives with other numbers ofdifferent fixed positions. Typically all the different fixed positionsand their respective different indentations are distributedsymmetrically about the axis of rotation of the driven wheel.

It will be understood that continuous rotation of the rotatable knob 106causes tube 100 to rotate about axis of symmetry 92 in discrete angularsteps. Thus, for the eight different fixed positions illustrated, by wayof example, in the figures, for driven wheel 120, tube 100 rotates toeight fixed positions, each fixed position separated from an adjacentfixed position by 45°. Once in one of the positions, tube 100 iseffectively locked in place, regardless of rotation of knob 106, untilthe knob has rotated sufficiently to initiate transfer of the tube to anadjacent fixed position.

FIG. 10 and FIG. 11 are schematic illustrations of portions of guidewire115 and balloon insertion mechanism 119, according to an embodiment ofthe present invention. In FIGS. 10 and 11 tube 100 has been hidden. FIG.10 shows a balloon 150, in its nondilated state, that is attached at itsproximal end to a distal end of an insertion rod 154 comprised in themechanism. Balloon 150 is attached at its distal end to a balloonholding tube 160, and the tube is sealed at its proximal end to thedistal tip of rod 154. Tube 160 is shown in a transparent form in FIG.11.

Tube 160 permits the passage of guidewire 115 through a lumen of thetube, and the guidewire is inserted into the tube via a first channel164 in rod 154. Channel 164 is also configured to transfer fluid, suchas irrigation fluid, through the channel, so that the fluid exits from adistal end of tube 160.

Guidewire 115 may comprise a magnetic sensor 32A at its distal end. Insome embodiments rod 154 may also comprise a magnetic sensor 32B at thedistal end of the rod. The sensors enable physician 54 to track theguidewire and rod 154 after they have been inserted into patient 22.

In some embodiments the distal end of the guidewire is deflectable,typically by having wires (not shown in the figure) leading from thedistal end to the proximal end, and adjustably tensioning the wires toform a desired deflection.

Rod 154 also comprises a second channel 170, that is used to convey airto the balloon so as to inflate the balloon. The channel may also beused to remove air so as to deflate the balloon.

FIG. 12 is a schematic transparent view of manifold 127, according to anembodiment of the present invention. Guidewire 115 is supported by themanifold, but is able to slide within it. A proximal end of rod 154 isfixed within the manifold and the manifold has channels connected tofirst channel 164 and second channel 170 (visible in FIGS. 10 and 11) ofthe rod, and respectively to a fluid supply tube 180 and an air supplytube 184.

FIG. 13 is a schematic sectional view of locking mechanism 131,according to an embodiment of the present invention. Mechanism 131 ismounted on ball-joint 112, and fixedly couples suction tube 124 to thehandle. As shown in the figure, suction tube 124 provides a channel intoenclosure 104, and so may be used by the physician for suction, therebywithdrawing material such as blood or mucus through tube 100 and theenclosure.

Rod 154 and guidewire 115 both traverse the mechanism, which comprises anut 192 turning on a screwed section 194. In an unlocked state of themechanism, when nut 192 is in the center of the screwed section, boththe rod and the guidewire are free to move, proximally and distally,within the mechanism and thus within tube 100 of tool 21. Movement ofrod 154 may be achieved by the physician pushing or pulling manifold127. Movement of the guidewire may be achieved by the physiciansqueezing a sponge-like cylinder 184 surrounding the guidewire, so as togrip the guidewire, and then moving the gripped guidewire proximally ordistally.

In a first locked state of the mechanism, which is implemented by thephysician turning nut 192 of the mechanism in a first direction so as toraise the nut, rod 154 is fixedly held by the locking mechanism againstknob 190 while guidewire 115 is free to move.

In a second locked state of the mechanism, which is implemented by thephysician turning nut 192 in a second direction, opposite the firstdirection, so as to lower the nut, guidewire 115 is fixedly held by thelocking mechanism while rod 154 is free to move.

During a typical sinuplasty procedure, physician 54 inserts tube 100 andsection 84 into patient 22 so that the distal end of section 84 is inproximity to the sinuplasty site. Prior to, or during, the insertion,the physician may rotate tube 100 and/or deflect section 84, asdescribed above, so as to best position the distal end of the section.

The physician may then use sponge-like cylinder 184 to thread guidewire115 through channel 164 of rod 154, and through the lumen of tube 100,until it exits the distal end of section 84. The physician typicallypositions the guidewire so that its distal end is beyond the site thatis set for sinuplasty.

With the guidewire in position, the physician may then slide the ballooninsertion mechanism, i.e., rod 154, along the guidewire until theballoon of the mechanism reaches the desired location, at which stagethe balloon may be locked in place by locking the balloon insertionmechanism with locking mechanism 131. Once in position, the balloon maybe inflated, to achieve the sinuplasty, by passing air into channel 170.

Once the sinuplasty procedure has been performed, the guidewire and rod154 may be withdrawn from the patient by reversing the steps above.

Although the embodiments described herein mainly address improvements ina tool for ENT, the methods and systems described herein may also beused in other, non-ENT applications, such as in neuro, gastric and otherlaparoscopic surgeries.

It will be appreciated that the embodiments described above are cited byway of example, and that the present invention is not limited to whathas been particularly shown and described hereinabove. Rather, the scopeof the present invention includes both combinations and subcombinationsof the various features described hereinabove, as well as variations andmodifications thereof which would occur to persons skilled in the artupon reading the foregoing description and which are not disclosed inthe prior art.

1. A tool, comprising: an enclosure; a rotatable knob retained by, andprotruding from, the enclosure; a tube having a proximal end retained bythe enclosure, the tube having an axis of symmetry; and a Geneva driveretained within the enclosure, the Geneva drive comprising a drive wheelfixedly attached to the rotatable knob and a driven wheel fixedlyattached to the proximal end of the tube, so that an axis of rotation ofthe driven wheel coincides with the axis of symmetry of the tube,whereby a continuous rotation of the rotatable knob causes the tube torotate about the axis of symmetry in discrete angular steps.
 2. The toolaccording to claim 1, wherein the Geneva drive has eight different fixedpositions.
 3. The tool according to claim 1, wherein the tube has adistal end having dimensions enabling it to be inserted into an orificeof a human patient.
 4. The tool according to claim 3, wherein theorifice comprises a nasal sinus.
 5. A method, comprising: providing anenclosure; positioning a rotatable knob to be retained by, and protrudefrom, the enclosure; positioning a tube having a proximal end to beretained by the enclosure, the tube having an axis of symmetry; andpositioning a Geneva drive to be retained within the enclosure, theGeneva drive comprising a drive wheel fixedly attached to the rotatableknob and a driven wheel fixedly attached to the proximal end of thetube, so that an axis of rotation of the driven wheel coincides with theaxis of symmetry of the tube, whereby a continuous rotation of therotatable knob causes the tube to rotate about the axis of symmetry indiscrete angular steps.
 6. The method according to claim 4, wherein theGeneva drive has eight different fixed positions.
 7. The methodaccording to claim 4, wherein the tube has a distal end havingdimensions enabling it to be inserted into an orifice of a humanpatient.
 8. The method according to claim 7, wherein the orificecomprises a nasal sinus.